None listed
Conditions
Brief summary
The purpose of this research study is to compare the rate of healing and your perception of pain associated with the treatment of your skin graft donor site. The donor site is the wound left behind when a skin graft has been taken. It is frequently a very uncomfortable wound which usually heals by itself in 10-14 days. Two different types of dressing are being studied. One dressing is currently used typically for donor site care in burn patients on the Burns Unit at the Royal Adelaide Hospital (Duoderm®). This dressing is approved by the Therapeutic Goods Administration for sale and use in Australia. AWBAT-D™ is approved by the Federal Drugs Administration for use and sale in the United States, but in Australia can only be used currently as part of a clinical trial (like this one). The decision regarding which dressing you will receive will be 'random'. If you require two separate donor sites, both materials will be used (one on each site.
Interventions
An appraisal of the two main outcomes in donor-site management (pain and time to healing) using two different dressings. Duoderm (a hydrocolloid and the current treatment of these wounds in our centre) and AWBAT-D (a new biosynthetic skin substitute specifically designed to expedite healing of these wounds). AWBAT-D consists of a wound surface of woven nylon matrix to which procine type 1 collagen fragments are bonded (matt), with a porous silicone outer surface (shiny). AWBAT-D is applied matt
An appraisal of the two main outcomes in donor-site management (pain and time to healing) using two different dressings. Duoderm (a hydrocolloid and the current treatment of these wounds in our centre) and AWBAT-D (a new biosynthetic skin substitute specifically designed to expedite healing of these wounds). AWBAT-D consists of a wound surface of woven nylon matrix to which procine type 1 collagen fragments are bonded (matt), with a porous silicone outer surface (shiny). AWBAT-D is applied matt side down, shiny side up. The material is overdressed with Acticoat nanocrystalline silver polyester dressing. AWBAT-D remains in situ until healing occurs when it detaches spontaneously after 10-14 days. If one patient has two donor sites which allow them to be their own control (ie both materials will be applied, one to each site), the site to receive AWBAT-D is allocated by randomisation table. Duoderm is applied to the other site (adhesive side to wound). There is always sufficient gap between the materials to prevent cross-contamination by wound exudate
Sponsors
Dr John E Greenwood AM
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Split-skin graft donor sites Two non-contiguous donor sites of the same approximate size for comparison (patient own control), OR One donor site to receive either AWBAT-D dressing OR Duoderm dressing Patient Age: 18 - 70 years
Exclusion criteria
Pregnancy/Lactation Ventilated patients (no consent) Non-English speakers (from an informed consent perspective) Co-morbidity which may compromise healing Known allergy to porcine products or religious issues with such products
Outcome results
None listed